FIRM FAILED TO ESTABLISH AND FOLLOW PROCEDURES DESIGNED TO PREVENT MICROBIOLOGICAL CONTAMINATION (21 CFR 211.113(b)) The FDA, during August and October 2012 inspected two Apotex, Inc. sites. This Blog only discusses the facilities located at 150 Signet Drive, Toronto, Canada. The U.S. Food and Drug Administration (FDA) identified significant … [Read more...]
HEMOFARM A.D., VRSAC, SERBIA, RECEIVES WARNING LETTER (6/20/12) FOR ASEPTIC PROCESSING ISSUES
EXAMINE HOW THE REVISED USP<1116> RELATES TO THESE OBSERVATIONS FIRM IS PLACED UNDER FDA IMPORT ALERT Hemofarm A.D., Vrsac, Serbia recently received a four Observation Warning Letter for unreliable environmental (to include microbiological) monitoring data. Several of the CGMP violations listed in their letter include … [Read more...]
